A Comparative Study of the Baska Mask Vs Proseal Laryngeal Mask Regarding Airway Sealing Pressure
- Conditions
- Baska Mask
- Registration Number
- NCT03812081
- Lead Sponsor
- Cairo University
- Brief Summary
Baska mask air way(BM) in comparative study with Proseal laryngeal mask airway (PLMA) regarding performance of Baska mask improves the safety and efficacy of airway management for in patients undergoing general anesthesia by mechanical ventilation confirmation of position by fiber optic view of glottis opening and success of gastric tube insertion , Airway sealing pressure, Leak fraction, insertion time and "overall insertion" success rates, and post-operative complications (airway trauma, hoarseness, sore throat and Dysphagia ).
- Detailed Description
Maintenance of a patent airway is a major responsibility for the anesthesiologists, interruption of gas exchange, even for a few minutes, can result in catastrophic outcomes such as brain damage or death.
Supraglottic airway devices are devices that ventilate patients by delivering anaesthetic gases/oxygen above the level of the vocal cord. Since the development of the laryngeal mask airway, many other supraglottic devices have been introduced in the clinical practice of airway management, trying to offer a simple and effective alternative to endotracheal tube.
However, following experience with such simple cases, clinicians soon become comfortable with more complex cases, such as cases of longer duration, cases with sicker patient reported favorable outcomes in safety profile, risk, ease of insertion, recovery of patients and cost analyses. However, there is an under reporting of complications aris¬ing during ventilation with this device and the risk factors associated with such complications in adult patients. These include Hypoxia, laryngospasm, and difficulty with insertion, suboptimal ventilation, bronchospasm, aspiration, desaturation, hy¬potension and conversion to intubation with ETT. These can be significantly serious and life threatening
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 74
- Healthy adult ASA I-II patients,
- Both genders, aged 18-45 years,
- Body weight between 50 and 90 kg who BMI > 30 kg/m2
- Non-urgent surgery of planned duration up to 2 hrs
- Patient refusal
- Patients having known tendency to nausea/vomiting or pharyngeal pathology
- Morbid obese patients with body mass index >30 kg/m2
- Patients known to have gastro-esophageal reflux disease (GERD), hiatus hernia or previous upper gastrointestinal tract surgery
- History of difficult intubation, measured the common predictive indices for difficult intubation (BMI, thyromental distance,Mallampati grade, inter-incisor distance, dentition and neck movement ).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Airway sealing pressure in cmH2O 15 Minutes The airway sealing pressure is the pressure at which leak starts; in cmH2O at 5 mints post placement, this leak pressure will calculate as the plateau airway pressure reach with fresh gas flow 6 l/min, and pressure adjustment valve set at 70 cmH2O, and observing of the rise of the ventilator's airway pressure.
A ''puffing'' sound was heard near the patient's mouth (release of pressure) indicating the airway seal pressure
- Secondary Outcome Measures
Name Time Method Device Complications: Through study completion Patients will be monitoring for the following complications: arterial oxygen desaturation, lip damage; blood staining on mask removal and laryngospasm, the incidence and severity of throat pain, dysphagia, Heart burn, Nausea and Vomiting at arrival and discharge from the recovery unit and on the first postoperative day
Laryngeal view grades recorded by fiberoptic bronchoscopes. 15 Minutes fiberoptic bronchoscopes can record Laryngeal view grades
Trial Locations
- Locations (1)
Ahmed Abdalla Mohamed
🇪🇬Cairo, Egypt